Proteina Selected for National New Drug Development Project... Accelerating Osteoarthritis Drug Technology Transfer and Clinical Entry

Proteina, an AI-driven drug development company specializing in big data of protein-protein interactions (Proteina), announced on June 18 that it has been selected for the non-clinical research project under the “2026 1st New Drug Development R&D Ecosystem Research” led by the National New Drug Development Project Group.

The official title of the project is “Preclinical efficacy and toxicity evaluation and pharmaceutical manufacturing and quality control (CMC) development research for the first-in-class entry of the novel mechanism-based osteoarthritis drug candidate PRT-101.” The ultimate objective is to obtain approval for Phase 1 clinical trials.

PRT-101 is a novel osteoarthritis drug candidate that directly regulates the SOX9 protein, a key transcription factor for cartilage formation. Existing osteoarthritis treatments work by alleviating pain or modulating signaling pathways related to cartilage generation. PRT-101, by directly targeting the key regulator of cartilage formation, aims to achieve structural regeneration and functional recovery of damaged cartilage, as well as pain relief.

PRT-101 recently presented superior preclinical results compared to Lorecivivint, a leading global Phase 3 clinical candidate, at the European Alliance of Associations for Rheumatology (EULAR 2026). In a severe osteoarthritis model disclosed by Proteina, PRT-101 demonstrated superiority across major evaluation indices, including cartilage regeneration and structural maintenance, pain relief, improvement of motor function, and amelioration of the inflammatory environment, thereby proving its potential as a next-generation disease-modifying osteoarthritis drug (DMOAD).

Proteina plans to conduct efficacy and toxicity evaluations of PRT-101 in rodents and non-rodent species, as well as CMC development for the pharmaceutical product. Based on this, the company aims to secure a data package that meets global new drug development standards by next year, laying the groundwork for Phase 1 clinical approval, future technology transfer, and global commercialization.

A Proteina representative stated, “This selection for the National New Drug Development Project provides an important opportunity to further advance PRT-101’s entry into clinical trials and its global commercialization potential,” adding, “In line with events such as the Osteoarthritis Research Society International (OARSI) and EULAR 2026, we are in discussions with several global pharmaceutical companies and plan to further refine strategies for technology transfer, joint development, and global commercialization.”

The National New Drug Development Project is a pan-ministry national R&D initiative launched to strengthen the global competitiveness of Korea’s pharmaceutical and biotechnology industries. Since 2021, it has aimed to reinforce the domestic new drug development R&D ecosystem, create outcomes for global commercialization, and generate public interest results in the healthcare sector by supporting all stages of new drug development over a 10-year period.

This content was produced with the assistance of AI translation services.